Generic Insulins Out of Reach for Now

| Mar 30, 2012

A Diabetes Health reader writes in to ask: Is there a generic alternative to Humalog insulin? If so, what is its cost compared to Humalog?

Generic drugs are amazing. They offer lifesaving promise for a cheap price tag, and given that the underlying drugs have been tested and proven, there's no doubt about safety or effectiveness. But don't expect to see generic "human" insulin any time soon. If you do spot it eventually, don't expect it to be too cheap or widespread.

It seems that the complex manufacturing involved in insulin drugs isn't easily duplicated. The processes are so complicated--and government guidance in the area so lacking--that there are still no generic alternatives to insulin brands with expired patents in the United States.

Humulin insulin, for example, saw its patent expire in 2000, but Eli Lilly still sold $1.3 billion worth of the brand last year. Lilly's patent on Humalog will expire next year, but its most worrisome competitor, a company in India associated with Pfizer, called off its generic insulin work in March. That's expected to keep Humalog sales strong into the near future.

Some semi-generic forms of human insulin are available in other countries, but they're called "biosimilars" because they're only similar, not identical, to the name brand stuff. Patients don't necessarily react to them in the same way.

The US Department of Health and Human Services is working on rules for these generic insulins, and a plant to manufacture them is being built. But companies will still have to run tests on the new insulins--something they don't have to do for most other generic drugs--which will slow their introduction even further.

Ultimately, insulin is a highly specialized drug that's used by a relatively small number of people. The complicated processes needed to make it are in the hands of a small number of companies. And while people overseas have access to "biosimilars," they are still a fraction of the market: $3 billion of $18 billion total.


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Categories: Biosimilars, Diabetes, Diabetes, Generic Alternatives to Insulin, Generic Drugs, Humalog Insulin, Humulin Insulin, Semi-Generic

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Posted by jlnhjm on 3 April 2012

I am an insulin user and under my Medicare advantage plan I get it without a co-pay. That is not to say it is free, the cost is added to my "allowance" for medications and insulin usage brings me ever closer to the donut hole. Lilly has a coupon program where I can get 10 free humalog pens a year, about half a year's supply for me. I shove the other half into my post donut hole coverage. Cannot do the same for levemir, tho I, once again, fill the max number of prescriptions post donut. Enough to bring me to next month, possibly the month after. Unfortunately, tho all my prescriptions but one are generic, they are still expensive. With verve and nerve, I have been shoving falling into the donut hole several months later. One year I fell in, crawled thru, and came back out the other side. What a horror! Point being, if insulin went generic, with adequate production, perhaps more people would use it to their good advantage and we would have fewer diabetics with complications. Compared to the cost of treating complications, generic insulin, even gov't produced, would be cheap.

Posted by Anonymous on 3 April 2012

Sembiosys in Canada is producing insulin "identical" to a specific insulin available here in the USA.

The dramatic news is that they bypass the complicated process of deriving pure insulin with traditional methods, by GROWING it using a genetically altered SAFFLOWER plant.

Our hope for sustainable insulin inventories as the need increases may lay with this technology.

Posted by Anonymous on 4 April 2012

Having been an insulin-dependent diabetic for 51 years (I'm 59), I've seen the prices for insulin skyrocket. In the mid '60s a bottle of Lente cost $8. By the late '70s it has risen to $28. I haven't used a long-acting insulin in 12 years since I started on a pump, but have used regular, then Novolog, now Humalog. Those have all skyrocketed in $ as well, in the neighborhood of 50-60% increases in the last 20 years. At this point a bottle of Humalog sells for $135, which I use at a low rate of about 1-1/2 vials a month. My understanding is that the drug companies must recoup their investments for research,development, FDA approval, and production, so a set time period for a patent to run is reasonable. What I can't understand is why the price keeps increasing even after the patent expires. The market is expanding, and is no longer the tiny niche market it used to be with the state of our national health! The manufacturers have already established their production facilities, marketing venues and distribution routes.... My suspicion for price raising at this point is "because they can". And insurance companies are happy with this situation because they never need to cover these brand-name insulins as anything but non-formulary medications, with the highest co-pay and poorest coverage. Without lots of money and insurance, many diabetics are unable to afford their basic care - resulting in worse health problems and disabilities and so on and so on.
From my perspective, the slow, lumbering, bureaucratic system exists largely to perpetuate itself, all in the name of protecting the consumers.

Posted by Anonymous on 5 April 2012

I don't understand the price 'gouging' either. Especially for a formula that has remained unaltered for some time now and most of the patents have expired. But, when was the last time they changed the formula for Bayer aspirin or Tylenol and those prices over the counter have also skyrocketed. It's a business and as long as supplies remain controlled and demand increases so does the prices.

There was a good article about the difficulties of actually producing insulin but at the same time I have a hard time believeing it is difficult to produce, knowing that it's been produced for >80 years now.

It's amazing how advanced smartphones are and I just saw a news clip for Goolge glasses that seems incredible and yet, diabetes technology seems so archaic by todays standards. The pumps are great but come on, they are still too big and cumbersome. Yes, we are far from boiling and sharpening needles but if we judge what we have today by TODAY'S standards, we are seriously lacking. It's all about market demand and T1 is a very small market when compared to other markets and that is why we don't have better technologies and cheaper drug options.

We can blame the FDA and to some extent they are to blame but that's also too easy and allows for a scape goat for big pharma and tech companies.

T1 is a niche market and while it remains so it will always be expensive. Most insuling pumps are >$5,000.00ea and they are glorified pagers! The Omnipod is the least expensive but what it's PDA does can most likely be done from an iPhone for the price of an app. But, where's the profit in that?

Posted by Anonymous on 7 April 2012

I too am shicked by the high cost of Humalog insulin. It cost me $300.00 the other day for a three month supply of humalog insulin (9 vials). I cannot afford that so it is either find another insulin or die (my funeral is all paid for so that would be cheaper in the end). I do not understand why the producers of Humalog would raise the price so high that the average person cannot afford it.... If anyone knows of a generic for Humalog or a substitute for humalog, I would appreciate knowing. Thank you.

Posted by Wanakure on 8 April 2012

Isn't it time to take the profits out? Don't France & Switzerland have non-profit private insurance companies and health care providers? Citizens get better healthcare and it costs less. Why not expand Medicare to cover everybody? Have you asked your representative to co-sponsor H.R. 676?

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